Example Data for Each Core Listing

(Illustrative examples only; data are fictitious)

Listing 1: Subject Disposition

Subject ID	Site	Country	Planned Treatment	Actual Treatment	Randomization Date	First Dose Date	Last Dose Date	Completed Treatment	Reason for Discontinuation
001-001	101	US	Arm A	Arm A	2022-01-10	2022-01-12	2022-06-15	No	Progressive Disease
001-002	101	US	Arm B	Arm B	2022-01-15	2022-01-17	2022-12-20	Yes	—

Listing 2: Demographics and Baseline Characteristics

Subject ID	Age	Sex	Race	BMI	ECOG	Stage	Metastasis	Treatment
001-001	62	Male	Asian	23.4	1	IV	Yes	Arm A
001-002	55	Female	Asian	21.8	0	III	No	Arm B

Listing 3: Treatment Exposure

Subject ID	Treatment	Start Date	End Date	Dose	Unit	Cumulative Dose	Dose Reduction	Interruption
001-001	Arm A	2022-01-12	2022-06-15	200	mg	3200	Yes	No
001-002	Arm B	2022-01-17	2022-12-20	150	mg	5400	No	No

Listing 4: Tumor Assessment by Visit (RECIST)

Subject ID	Visit	Assessment Date	Overall Response	Baseline	Assessor	Treatment
001-001	Baseline	2022-01-08	SD	Yes	Investigator	Arm A
001-001	Week 6	2022-02-20	PR	No	Investigator	Arm A
001-001	Week 12	2022-04-05	PD	No	Investigator	Arm A

Listing 5: Best Overall Response (BOR)

Subject ID	Best Overall Response	First Response Date	ORR	DCR	Treatment
001-001	PR	2022-02-20	Yes	Yes	Arm A
001-002	SD	—	No	Yes	Arm B

Listing 6: Progression-Free Survival (PFS) Details

Subject ID	Start Date	Event/Censor Date	Event	Event Type	PFS (Days)	Treatment
001-001	2022-01-10	2022-04-05	Yes	Progression	86	Arm A
001-002	2022-01-15	2022-12-20	No	Censored	339	Arm B

Listing 7: Overall Survival (OS) Details

Subject ID	Start Date	Death/Censor Date	Death	OS (Days)	Treatment
001-001	2022-01-10	2022-11-30	Yes	325	Arm A
001-002	2022-01-15	2023-03-01	No	410	Arm B

Listing 8: Duration of Response (DoR)

(Responders Only)

Subject ID	First Response Date	Event/Censor Date	Event	DoR (Days)	Treatment
001-001	2022-02-20	2022-04-05	Yes	45	Arm A

Listing 9: Adverse Events

Subject ID	SOC	Preferred Term	Severity	SAE	Treatment Related	Action Taken	Outcome
001-001	Gastrointestinal	Nausea	Grade 2	No	Yes	Symptomatic Tx	Resolved
001-001	Hematologic	Neutropenia	Grade 3	Yes	Yes	Drug Interrupted	Recovered

Listing 10: Laboratory Results

Subject ID	Test	Date	Result	Unit	Baseline	Normal Range	Abnormal	CTCAE Grade
001-001	ALT	2022-03-01	85	U/L	32	0–40	High	2
001-002	Hemoglobin	2022-02-15	98	g/L	120	110–160	Low	2

Listing 11: Protocol Deviations

Subject ID	Deviation Category	Description	Severity	Impacts Primary Analysis
001-001	Dosing	Dose delayed >7 days	Moderate	No
001-002	Assessment	One tumor assessment missed	Minor	No

✅ Regulatory Summary Statement (Reusable)

The above 11 listings represent the minimum and sufficient subject-level listing set for a registrational oncology study.
Together, they ensure complete traceability, auditability, and validation of all primary efficacy, safety, and disposition results presented in tables and figures.

Listing → ADaM → SDTM

Four-Column Traceability Matrix (Oncology Registrational Study)

Notes

Listing: CSR listing title
ADaM Dataset: Dataset used to generate the listing
ADaM Variable: Key variables displayed or used for determination
SDTM Source: Final SDTM domain(s) or derivation path